NCT05265429

Brief Summary

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2023Aug 2027

First Submitted

Initial submission to the registry

February 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

4.6 years

First QC Date

February 16, 2022

Last Update Submit

October 28, 2025

Conditions

Keywords

Non Small Cell Lung CancerSmall Cell Lung CarcinomaGeneticsGenomicsYoung lung cancer

Outcome Measures

Primary Outcomes (1)

  • Repository of specimens and data

    Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.

    5 years or study closure

Secondary Outcomes (3)

  • Number of patients with targetable somatic alterations in known oncogenic driver genes

    5 years or study closure

  • Number of patients with predicted oncogenic alterations in unknown driver genes

    5 years or study closure

  • Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes

    5 years or study closure

Study Arms (1)

Data/Biospecimen Collection

Tumor and saliva specimens from participants with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosed at age 45 or younger

Genetic: Data and Specimen Collection

Interventions

* Provide research team access to relevant medical records * Answer two (2) short questionnaires at time of consent * Provide up to 5 tubes (37 ml) of blood at or near the time of consent, and/or saliva sample * Consider consenting to other optional parts of the research such as: * Providing additional blood or tissue samples in the future (optional) * Providing permission for obtainment of stored tissue specimens from lung cancer surgeries or biopsies from the pathology departments where they have been stored (optional)

Data/Biospecimen Collection

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis

You may qualify if:

  • Age 45 and under at lung cancer diagnosis
  • Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
  • Provision of written informed consent
  • Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
  • Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

You may not qualify if:

  • Individuals who decline to sign consent
  • Individuals who are unable to give consent or assent and are without a designated healthcare proxy
  • Compromise of patient diagnosis or staging if tissue is used for research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Pasi A Janne, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pasi A Janne, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 3, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations